BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MYNX VASCULAR CLOSURE DEVICE

    MDR report key: 2022679 · Received March 17, 2011

    Report

    Report Number
    3004939290-2011-00030
    Event Type
    Injury
    Date Received
    March 17, 2011
    Date of Event
    February 15, 2011
    Report Date
    February 17, 2011
    Manufacturer
    ACCESSCLOSURE, INC
    Product Code
    MGB
    PMA / PMN Number
    P040044
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE PROVIDED INFORMATION AND THE INVESTIGATION PERFORMED, THE CAUSE OF THE REPORTED EVENT COULD NOT BE DETERMINED. THE REVIEW OF THE LHR (LOT F1032406) INDICATED THAT THE MYNX DEVICE MET ALL ESTABLISHED PERFORMANCE CRITERIA PRIOR TO SHIPMENT.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE ACI SALES PROFESSIONAL THAT A PATIENT UNDERWENT A DIAGNOSTIC CORONARY CATHETERIZATION PROCEDURE ON (B)(6) 2011. A 6F PROCEDURAL SHEATH WAS USED TO OBTAIN ACCESS AT THE COMMON FEMORAL ARTERY (CFA). A PRE-PROCEDURAL FEMORAL ANGIOGRAM SHOWED A LARGE ARTERY FREE OF PVD AND CALCIUM. FOLLOWING THE PROCEDURE, THE PHYSICIAN TRAINED TO THE MYNX PROCEDURE, CHOSE THE DEVICE FOR FEMORAL ARTERIAL CLOSURE. IT WAS REPORTED THAT THE MYNX WAS PREPPED AND DEPLOYED PER THE IFU. REPORTEDLY, THE RADIOLOGY TECHNOLOGIST (RT) DEPLOYED THE MYNX WITHOUT ANY ISSUES AND THEN PULLED VACUUM TO DEFLATE THE BALLOON. AFTER SEVERAL MINUTES, THE RT REALIZED THAT THE BALLOON WOULD NOT DEFLATE. THE PHYSICIAN WAS CALLED BACK INTO THE CATH LAB AND THE PHYSICIAN USED AN ACCESS NEEDLE TO RUPTURE THE BALLOON. THE PHYSICIAN WAS ABLE TO REMOVE THE ENTIRE DEVICE WITHOUT THE PATIENT EXPERIENCING ANY COMPLICATION. THE PATIENT WAS AMBULATED AND DISCHARGED TO HOME WITHOUT CLINICAL SEQUELA. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MYNX VASCULAR CLOSURE DEVICE MGB MGB ACCESSCLOSURE, INC MX6701 F1032406

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention